On July 13th, Dr. Chow attended an ODAC (Oncologic Drug Advisory Committee) meeting as a voting member representing statistical experts at FDA in Silver Spring, Maryland.
This ODAC meeting reviewed two regulatory submissions: one is ABP215 (BLA761028) sponsored by Amgen. ABP215 is a proposed biosimilar product to Geneetch’s Avastin, which was approved by the FDA on February 26, 2004. The other one is MYL-1401O (BLA 761074) sponsored by Mylan. MYL 1401O is a proposed biosimilar to Genetech’s Herceptin, which was approved by the FDA on September 25, 1998.
Dr. Chow was appointed as a special government employee (SGE) by the FDA in June 2015. The appointment of SGE requires Dr. Chow to serve as a voting committee member at ODAC meetings and to serve as an expert statistical consultant to the FDA.